IT201600075405A1 - COMPOSITIONS FOR THE TREATMENT OF THE MENOPAUSE SYMPTOMS - Google Patents
COMPOSITIONS FOR THE TREATMENT OF THE MENOPAUSE SYMPTOMSInfo
- Publication number
- IT201600075405A1 IT201600075405A1 IT102016000075405A IT201600075405A IT201600075405A1 IT 201600075405 A1 IT201600075405 A1 IT 201600075405A1 IT 102016000075405 A IT102016000075405 A IT 102016000075405A IT 201600075405 A IT201600075405 A IT 201600075405A IT 201600075405 A1 IT201600075405 A1 IT 201600075405A1
- Authority
- IT
- Italy
- Prior art keywords
- treatment
- extract
- compositions
- composition
- resveratrol
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title description 31
- 230000009245 menopause Effects 0.000 title description 11
- 244000281702 Dioscorea villosa Species 0.000 description 16
- 235000000504 Dioscorea villosa Nutrition 0.000 description 15
- QNVSXXGDAPORNA-UHFFFAOYSA-N Resveratrol Natural products OC1=CC=CC(C=CC=2C=C(O)C(O)=CC=2)=C1 QNVSXXGDAPORNA-UHFFFAOYSA-N 0.000 description 14
- 235000021283 resveratrol Nutrition 0.000 description 14
- 229940016667 resveratrol Drugs 0.000 description 14
- LUKBXSAWLPMMSZ-OWOJBTEDSA-N Trans-resveratrol Chemical compound C1=CC(O)=CC=C1\C=C\C1=CC(O)=CC(O)=C1 LUKBXSAWLPMMSZ-OWOJBTEDSA-N 0.000 description 13
- 238000002360 preparation method Methods 0.000 description 11
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- WQLVFSAGQJTQCK-UHFFFAOYSA-N diosgenin Natural products CC1C(C2(CCC3C4(C)CCC(O)CC4=CCC3C2C2)C)C2OC11CCC(C)CO1 WQLVFSAGQJTQCK-UHFFFAOYSA-N 0.000 description 8
- 208000033830 Hot Flashes Diseases 0.000 description 7
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- HKQYGTCOTHHOMP-UHFFFAOYSA-N formononetin Chemical compound C1=CC(OC)=CC=C1C1=COC2=CC(O)=CC=C2C1=O HKQYGTCOTHHOMP-UHFFFAOYSA-N 0.000 description 2
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- FJKROLUGYXJWQN-UHFFFAOYSA-N papa-hydroxy-benzoic acid Natural products OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 229940067107 phenylethyl alcohol Drugs 0.000 description 2
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- 229960004889 salicylic acid Drugs 0.000 description 2
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- RIKPNWPEMPODJD-UHFFFAOYSA-N formononetin Natural products C1=CC(OC)=CC=C1C1=COC2=CC=CC=C2C1=O RIKPNWPEMPODJD-UHFFFAOYSA-N 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 229940045109 genistein Drugs 0.000 description 1
- TZBJGXHYKVUXJN-UHFFFAOYSA-N genistein Natural products C1=CC(O)=CC=C1C1=COC2=CC(O)=CC(O)=C2C1=O TZBJGXHYKVUXJN-UHFFFAOYSA-N 0.000 description 1
- 235000006539 genistein Nutrition 0.000 description 1
- ZCOLJUOHXJRHDI-CMWLGVBASA-N genistein 7-O-beta-D-glucoside Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=CC(O)=C2C(=O)C(C=3C=CC(O)=CC=3)=COC2=C1 ZCOLJUOHXJRHDI-CMWLGVBASA-N 0.000 description 1
- 235000011187 glycerol Nutrition 0.000 description 1
- 239000010460 hemp oil Substances 0.000 description 1
- 239000003688 hormone derivative Substances 0.000 description 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 1
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- AEIJTFQOBWATKX-UHFFFAOYSA-N octane-1,2-diol Chemical compound CCCCCCC(O)CO AEIJTFQOBWATKX-UHFFFAOYSA-N 0.000 description 1
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- 150000002989 phenols Chemical class 0.000 description 1
- 239000002243 precursor Substances 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 239000000186 progesterone Substances 0.000 description 1
- 229960003387 progesterone Drugs 0.000 description 1
- 150000003180 prostaglandins Chemical class 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 238000011867 re-evaluation Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- NWMIYTWHUDFRPL-UHFFFAOYSA-N sapogenin Natural products COC(=O)C1(CO)C(O)CCC2(C)C1CCC3(C)C2CC=C4C5C(C)(O)C(C)CCC5(CCC34C)C(=O)O NWMIYTWHUDFRPL-UHFFFAOYSA-N 0.000 description 1
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- 210000004243 sweat Anatomy 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- WZDGZWOAQTVYBX-XOINTXKNSA-N tibolone Chemical compound C([C@@H]12)C[C@]3(C)[C@@](C#C)(O)CC[C@H]3[C@@H]1[C@H](C)CC1=C2CCC(=O)C1 WZDGZWOAQTVYBX-XOINTXKNSA-N 0.000 description 1
- 229960001023 tibolone Drugs 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
- A23L33/11—Plant sterols or derivatives thereof, e.g. phytosterols
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/05—Phenols
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Botany (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Engineering & Computer Science (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Nutrition Science (AREA)
- Polymers & Plastics (AREA)
- Food Science & Technology (AREA)
- Medicines Containing Plant Substances (AREA)
Description
"COMPOSIZIONI PER IL TRATTAMENTO DELLA SINTOMATOLOGIA "COMPOSITIONS FOR THE TREATMENT OF SYMPTOMS
DELLA MENOPAUSA " OF THE MENOPAUSE "
DESCRIZIONE DESCRIPTION
La presente invenzione si riferisce a composizioni comprendenti un estratto di trifoglio rosso, resveratrolo e un estratto di dioscorea villosa. La presente invenzione si riferisce anche all’uso topico o transdermico di tali composizioni nella prevenzione e/o trattamento della sintomatologia della menopausa. The present invention relates to compositions comprising a red clover extract, resveratrol and a dioscorea villosa extract. The present invention also refers to the topical or transdermal use of these compositions in the prevention and / or treatment of menopause symptoms.
STATO DELLA TECNICA ANTERIORE STATE OF THE PRIOR ART
Nei decenni passati la ricerca farmacologica si è sforzata di trovare preparati che più si avvicinassero alla richiesta di ridurre i problemi legati alla menopausa come ad esempio le vampate di calore, secchezza vaginale, insonnia, protezione cardiovascolare e la perdita della massa ossea. La TOS, acronimo di Terapia Ormonale Sostitutiva, è una terapia che prevede l’uso di numerosi preparati a base di Estrogeni, come ad esempio l’estradiolo. Associazioni estroprogestiniche e preparati che si comportavano da estrogeno, progestinico e androgeno come il Tibolone sono stati usati come terapia nel trattamento dei disturbi associati alla menopausa. Il fine era quello di risolvere le problematiche e limitare gli effetti collaterali di lungo periodo che, per gli ormoni di sintesi, non sono da sottovalutare. La sorveglianza clinica sugli effetti a lungo tempo ha portato ad una rivalutazione di tutti i preparati ed ad una scomparsa di fatto della TOS, tranne per quei preparati che mantenevano una attività estroprogestinica che più proteggeva la donna dagli effetti negativi a lungo tempo. Sono state proposte terapie alternative a base di derivati della Soia, nonostante le aspettative però queste terapie si sono rilevate molto limitate in quanto non hanno mostrato un efficacia paragonabile alla TOS. In the past decades, pharmacological research has tried to find preparations that come closest to the request to reduce problems related to menopause such as hot flashes, vaginal dryness, insomnia, cardiovascular protection and bone loss. HRT, which stands for Hormone Replacement Therapy, is a therapy that involves the use of numerous estrogen-based preparations, such as estradiol. Combinations of estrogen-progestogen and preparations that behaved from estrogen, progestin and androgen such as Tibolone have been used as therapy in the treatment of disorders associated with menopause. The aim was to solve the problems and limit the long-term side effects which, for synthetic hormones, are not to be underestimated. Clinical surveillance on long-term effects led to a re-evaluation of all preparations and a de facto disappearance of HRT, except for those preparations which maintained an estrogen-progestogen activity which most protected the woman from long-term adverse effects. Alternative therapies based on soy derivatives have been proposed, despite expectations, however, these therapies have been found to be very limited as they have not shown an efficacy comparable to HRT.
In letteratura è riportato che la diosgenina, uno steroide estratto principalmente dai tuberi di Dioscorea Villosa (Wild Yam), non ha mostrato un valido effetto progestinico simile al progesterone naturale (Tucci et al. Biomed Sci Instrum.2003;39:341-6.). In the literature it is reported that diosgenin, a steroid extracted mainly from the tubers of Dioscorea Villosa (Wild Yam), did not show a valid progestin effect similar to natural progesterone (Tucci et al. Biomed Sci Instrum. 2003; 39: 341-6. ).
Più recentemente Ghazanfarpour et al. (J Obstet Gynaecol. 2016) hanno valutato l'efficacia del trifoglio rosso somministrato per via orale nell’alleviare le vampate di calore e altri sintomi della menopausa nelle donne in peri-post menopausa, la somministrazione dell’estratto per via orale non è però risultata particolarmente efficace. More recently Ghazanfarpour et al. (J Obstet Gynaecol. 2016) evaluated the efficacy of orally administered red clover in relieving hot flashes and other menopausal symptoms in peri-postmenopausal women, however, administration of the extract orally is not proved to be particularly effective.
Alla luce di quanto sopra detto è quindi molto sentito il problema di fornire nuovi prodotti efficaci nella prevenzione e trattamento dei disturbi associati alla menopausa. In light of the above, the problem of providing new products effective in the prevention and treatment of disorders associated with menopause is therefore very acute.
SOMMARIO DELL'INVENZIONE SUMMARY OF THE INVENTION
La presente invenzione si basa sulla selezione di alcune sostanze la cui associazione è risultata particolarmente efficace nel trattamento dei disturbi connessi alla menopausa. In particolare gli inventori hanno mostrato che la somministrazione topica o transdermica di una composizione comprendente come principi attivi estratto di trifoglio rosso, resveratrolo e un estratto di dioscorea villosa permette di eliminare i disturbi più gravi associati alla menopausa. The present invention is based on the selection of some substances whose association has been found to be particularly effective in the treatment of disorders connected with menopause. In particular, the inventors have shown that the topical or transdermal administration of a composition comprising as active ingredients red clover extract, resveratrol and a villous dioscorea extract allows to eliminate the most serious disorders associated with menopause.
La presente invenzione presenta diversi vantaggi tra cui: The present invention has several advantages including:
-Riduzione sostanziale delle vampate e sudorazione in dieci/quindici giorni. -Substantial reduction of hot flashes and sweating in ten / fifteen days.
-Miglioramento del trofismo vaginale in tempi rapidi. -Improvement of vaginal trophism in a short time.
-Perfetto bilanciamento delle azioni similestrogeniche/similprogestiniche. -Perfect balance of estrogenic / progestogen-like actions.
-Non significativi effetti collaterali da ascrivere ai componenti principali. -No significant side effects to be attributed to the main components.
-Effetto migliorativo sul contenuto minerale osseo del preparato. - Improving effect on the bone mineral content of the preparation.
-Sicuro effetto della diosgenina sul mantenimento della massa ossea. -Safe effect of diosgenin on the maintenance of bone mass.
Inoltre la somministrazione per via transdermica dei tre ingredienti permette un rapido assorbimento e quindi un rapido raggiungimento dello steady state, che si traduce in una migliore velocità di azione. In più l’effetto protettivo dell’attività progestinica della diosgenina controlla l’effetto estrogenico del Trifoglio Rosso e del Resveratrolo. Furthermore, the transdermal administration of the three ingredients allows a rapid absorption and therefore a rapid achievement of the steady state, which translates into a better speed of action. In addition, the protective effect of the progestin activity of diosgenin controls the estrogenic effect of Red Clover and Resveratrol.
Un primo oggetto della presente invenzione è una composizione, in particolare per uso topico o transdermico, comprendente un estratto di trifoglio rosso, resveratrolo e un estratto di dioscorea villosa. A first object of the present invention is a composition, in particular for topical or transdermal use, comprising an extract of red clover, resveratrol and an extract of dioscorea villosa.
Un secondo oggetto della presente invenzione è una composizione comprendente un estratto di trifoglio rosso, resveratrolo e un estratto di dioscorea villosa per uso in un metodo di prevenzione e/o di trattamento di uno o più disturbi associati alla menopausa. A second object of the present invention is a composition comprising a red clover extract, resveratrol and a dioscorea villosa extract for use in a method of prevention and / or treatment of one or more disorders associated with menopause.
Un terzo oggetto è un metodo per la preparazione di una composizione come sopra definita comprendente una passaggio di miscelazione di un estratto di trifoglio rosso con il resveratrolo e con un estratto di dioscorea villosa. A third object is a method for preparing a composition as defined above comprising a step of mixing a red clover extract with resveratrol and a villous dioscorea extract.
DESCRIZIONE DETTAGLIATA DELL'INVENZIONE DETAILED DESCRIPTION OF THE INVENTION
La presente invenzione si riferisce ad una composizione comprendente o consistente in una miscela di estratto di trifoglio rosso, resveratrolo e un estratto di dioscorea villosa. The present invention relates to a composition comprising or consisting of a mixture of red clover extract, resveratrol and a dioscorea villosa extract.
Il resveratrolo è un composto fenolico antiossidante in grado di prevenire l'ossidazione delle LDL e inibire la produzione di eicosanoidi quali le prostaglandine, leucotrieni e trobossani, coinvolti nei processi infiammatori e l'aggregazione piastrinica. Inoltre promuove la produzione di ossido nitrico, riduce i livelli di colesterolo e trigliceridi. Il resveratrolo usato nelle composizioni potrà essere ottenuto da diverse fonti naturali secondo metodiche standard o direttamente acquistato. La concentrazione di resveratrolo potrà essere compresa tra l’1,0% ed il 10,0% in peso, preferibilmente tra l’1,0% ed 5,0% in peso. Resveratrol is an antioxidant phenolic compound capable of preventing the oxidation of LDL and inhibiting the production of eicosanoids such as prostaglandins, leukotrienes and troboxanes, involved in inflammatory processes and platelet aggregation. It also promotes the production of nitric oxide, reduces cholesterol and triglyceride levels. The resveratrol used in the compositions can be obtained from different natural sources according to standard methods or directly purchased. The resveratrol concentration may be between 1.0% and 10.0% by weight, preferably between 1.0% and 5.0% by weight.
Il trifoglio rosso (Trifolium pratense) ha delle foglie ricche di Biocanina un precursore della genisteina, formononetina, Daodzeina, con proprietà utili nel ridurre le vampate di calore, irritabilità, pelle trofica ed astenia. L’estratto di trifoglio rosso usato nelle composizioni potrà essere ottenuto attraverso diversi metodi di preparazione noti al tecnico del settore, ad esempio mediante estrazione idroalcolica dalle foglie secche o fresche della pianta. La concentrazione dell’estratto di trifoglio rosso nella composizione potrà essere compresa tra l’1,0% ed il 10,0% in peso, preferibilmente tra 1,0 ed 8,0% in peso. Nell’estratto la concentrazione di principi attivi del trifoglio è circa un 10%. Red clover (Trifolium pratense) has leaves rich in Biocanina a precursor of genistein, formononetin, Daodzeina, with useful properties in reducing hot flashes, irritability, trophic skin and asthenia. The red clover extract used in the compositions can be obtained through various preparation methods known to those skilled in the art, for example by hydroalcoholic extraction from the dry or fresh leaves of the plant. The concentration of the red clover extract in the composition may be between 1.0% and 10.0% by weight, preferably between 1.0 and 8.0% by weight. In the extract, the concentration of active ingredients of the clover is about 10%.
La Dioscorea villosa è una specie di pianta tuberosa diffusa specialmente in Nord America. L’estratto di Dioscorea villosa usato nelle composizioni, potrà essere ottenuto attraverso diversi metodi di preparazione noti al tecnico del settore, preferibilmente sarà usato un estratto di radice ottenuto ad esempio mediante il procedimento brevettato “naviglio estrattore” descritto nel brevetto Italiano Num 1311185 concesso in data 4 marzo 2002. Preferibilmente l’estratto di Dioscorea villosa comprenderà almeno il 5% in peso di diosgenina, ad esempio una concentrazione tra il 5 ed il 20% in peso dell’estratto. La concentrazione dell’estratto di Dioscorea villosa nelle composizioni potrà essere compresa ad esempio tra il 1,0 ed il 30,0% in peso, preferibilmente tra il 10,0 ed 25,0% in peso. Dioscorea villosa is a species of tuberous plant widespread especially in North America. The extract of Dioscorea villosa used in the compositions can be obtained through various preparation methods known to the skilled in the art, preferably a root extract obtained for example by means of the patented "naviglio extractor" procedure described in the Italian patent No. 1311185 granted in date 4 March 2002. Preferably the Dioscorea villosa extract will comprise at least 5% by weight of diosgenin, for example a concentration between 5 and 20% by weight of the extract. The concentration of the Dioscorea villosa extract in the compositions may be comprised, for example, between 1.0 and 30.0% by weight, preferably between 10.0 and 25.0% by weight.
La diosgenina è una sapogenina derivata dalla pianta Dioscorea villosa ed è stata usata come materiale di partenza per la sintesi di ormoni steroidei. Secondo una forma di realizzazione la concentrazione di diosgenina nelle composizioni sarà compresa tra 0,5 mg e 2,5 mg per 100 ml di composizione Diosgenin is a sapogenin derived from the Dioscorea villosa plant and has been used as a starting material for the synthesis of steroid hormones. According to one embodiment, the concentration of diosgenin in the compositions will be between 0.5 mg and 2.5 mg per 100 ml of composition
La composizione potrà contenere uno o più tra agenti veicolanti, diluenti, eccipienti, emulsionanti, emollienti, conservanti, fattori di consistenza, regolatori di pH, antiossidanti idonei alla realizzazione di formulazioni (cosmetiche, farmaceutiche o dispositivi medici) per uso topico o transdermico come ad esempio uno o più composti scelti tra etanolo, alcol feniletilico, caprilil glicole, acido salicilico, idrossido di sodio, acrilati con catena di carbonio C10-30, glicerina, olio di canapa e/o cera d’api. The composition may contain one or more of carrier agents, diluents, excipients, emulsifiers, emollients, preservatives, consistency factors, pH regulators, antioxidants suitable for making formulations (cosmetic, pharmaceutical or medical devices) for topical or transdermal use such as for example one or more compounds selected from ethanol, phenylethyl alcohol, caprylyl glycol, salicylic acid, sodium hydroxide, acrylates with C10-30 carbon chain, glycerin, hemp oil and / or beeswax.
Tali composizioni potranno essere preparate secondo le tecniche note al tecnico del settore utilizzando i composti sopra descritti, ad esempio miscelando i singoli composti direttamente durante la preparazione della composizione o aggiungendo ai veicolanti e/o diluenti e/o eccipienti una miscela dei composti precedentemente preparati. These compositions can be prepared according to the techniques known to those skilled in the art using the compounds described above, for example by mixing the individual compounds directly during the preparation of the composition or by adding a mixture of the previously prepared compounds to the carriers and / or diluents and / or excipients.
La composizione secondo la presente invenzione potrà essere realizzata in forma di composizione cosmetica, farmaceutica, oppure di dispositivo medico secondo una qualsiasi delle classi descritte nella Direttiva CEE 93/42 sui dispositivi medici (che comprende anche sostanze e non solo “dispositivi” nel senso meccanico del termine), o in qualsiasi forma secondo le disposizioni del paese in cui tale composizione sarà prodotta. The composition according to the present invention can be made in the form of a cosmetic, pharmaceutical composition or a medical device according to any of the classes described in the EEC Directive 93/42 on medical devices (which also includes substances and not only "devices" in the mechanical sense of the term), or in any form according to the provisions of the country where such composition will be produced.
Quando realizzata in forma di composizione cosmetica o farmaceutica i componenti utilizzati così come gli eccipienti saranno di grado cosmeticamente o farmaceuticamente accettabile per l’uso desiderato (topico o transdermico in questo caso). Le composizioni per uso topico secondo la presente invenzione potranno essere in una forma qualsiasi scelta tra gel, unguento, crema, pomata, schiuma, polvere, spray, emulsione olio in acqua, emulsione acqua in olio, emulsione olio in gel, emulsione gel in olio, sospensione, paste. Secondo una forma di realizzazione la composizione potrà essere inserita in un contenitore/erogatore idoneo all’erogazione ad esempio di 1,0-1,5 ml per puff. When made in the form of a cosmetic or pharmaceutical composition, the components used as well as the excipients will be of a cosmetically or pharmaceutically acceptable grade for the desired use (topical or transdermal in this case). The compositions for topical use according to the present invention may be in any form chosen from gel, ointment, cream, ointment, foam, powder, spray, oil-in-water emulsion, water-in-oil emulsion, oil-gel emulsion, gel-in-oil emulsion. , suspension, pastes. According to an embodiment, the composition can be inserted into a container / dispenser suitable for dispensing, for example, 1.0-1.5 ml per puff.
Sono oggetto della presente invenzione anche le composizioni come sopra descritte per uso in un metodo di prevenzione e/o di trattamento di uno più disturbi associati alla menopausa. Tali disturbi potranno essere uno o più dei seguenti: vampate di calore, sudore, diminuzione della libido, secchezza vaginale, umore, affaticamento, artralgia, mialgia generale, insonnia. Secondo un esempio non limitativo la composizione della presente invenzione potrà essere somministrata una o più volte al giorno mediante applicazione locale (topica) per un periodo di tempo ad esempio di 1, 2, 3, 4 settimane o anche superiore, ad esempio 1, 2 o 3 mesi. Secondo una forma di realizzazione sarà somministrata almeno una, due o tre volte al giorno, per almeno un mese. I regimi di somministrazione potranno variare in base alla risposta del paziente al trattamento. Sono di sotto riportati esempi che hanno lo scopo di illustrare meglio la presente invenzione e alcune forme di realizzazione specifiche, tali esempi non sono in alcun modo da considerare come una limitazione della precedente descrizione e delle successive rivendicazioni. Also object of the present invention are the compositions as described above for use in a method of prevention and / or treatment of one or more disorders associated with menopause. These disorders may be one or more of the following: hot flashes, sweat, decreased libido, vaginal dryness, mood, fatigue, arthralgia, general myalgia, insomnia. According to a non-limiting example, the composition of the present invention can be administered one or more times a day by local (topical) application for a period of time for example 1, 2, 3, 4 weeks or even longer, for example 1, 2 or 3 months. According to one embodiment, it will be administered at least once, two or three times a day, for at least one month. The regimens of administration will vary according to the patient's response to treatment. Examples are reported below which have the purpose of better illustrating the present invention and some specific embodiments, such examples are in no way to be considered as a limitation of the previous description and subsequent claims.
ESEMPIO 1 PREPARAZIONE DELLA COMPOSIZIONE EXAMPLE 1 PREPARATION OF THE COMPOSITION
- Estrazione standard del Trifoglio Rosso (pianta fresca) in soluzione idroalcolica. - Estrazione da radice di dioscorea (pianta fresca) tramite tecnologia brevettata “naviglio estrattore” come descritta nel brevetto dal titolo D. NAVIGLIO, ESTRATTORE RAPIDO SOLIDO-LIQUIDO DINAMICO BREVETTO CONCESSO IN DATA 4 MARZO 2002 – N° 1311185 - Standard extraction of Red Clover (fresh plant) in hydroalcoholic solution. - Extraction from dioscorea root (fresh plant) using patented "naviglio extractor" technology as described in the patent entitled D. NAVIGLIO, DYNAMIC FAST SOLID-LIQUID EXTRACTOR PATENT GRANTED ON 4 MARCH 2002 - N ° 1311185
- Resveratrolo in polvere (commercialmente disponibile). - Resveratrol powder (commercially available).
- Ottenute le tinture madri si è provveduto a ricostituire l’emulsione con i seguenti componenti e le rispettive percentuali: - Once the mother tinctures were obtained, the emulsion was reconstituted with the following components and their respective percentages:
Tabella 1 percentuali delle sostanze usate nella preparazione della composizione in gel Table 1 percentages of substances used in the preparation of the gel composition
SOSTANZA INTERVALLO (VALORE p/p) SUBSTANCE RANGE (p / p VALUE)
Acqua 50-75% Water 50-75%
Etanolo 10-25% Ethanol 10-25%
Resveratrolo 1-5% Resveratrol 1-5%
Dioscorea villosa radice 1-5% Dioscorea villosa root 1-5%
Trifolium pratense parte aerea 0,1-1% Trifolium pratense aerial part 0.1-1%
Alcol feniletilico 0,1-1% Phenylethyl alcohol 0.1-1%
Caprilil glicole 0,1-1% Caprilyl glycol 0.1-1%
Acido salicilico 0.1-1% Salicylic acid 0.1-1%
Idrossido di sodio 0.1-1% Sodium hydroxide 0.1-1%
Acrilati/C10-30 ≤ 0,1% Acrylates / C10-30 ≤ 0.1%
Crosspolimeri Crosspolymers
Alchil acrilati Alkyl acrylates
2. DATI SPERIMENTALI 2. EXPERIMENTAL DATA
2.1 Materiali e metodi 2.1 Materials and methods
Sono state seguite 45 donne in menopausa conclamata (amenorrea, alti livelli di FSH e LH). Le pazienti sono state sottoposte ad una prima visita che ha incluso la storia, l’esame fisico e la compilazione del questionario Greene sui sintomi climaterici. Le pazienti dovevano attribuire un punteggio da 0 a 3 in base alla presenza e la frequenza dei disturbi elencati: meno di 7 vampate al giorno, sudore, diminuzione della libido, secchezza vaginale, umore, affaticamento, artralgia, mialgia generale, insonnia. 45 women in full menopause (amenorrhea, high levels of FSH and LH) were followed. The patients underwent a first visit that included the history, physical examination and completion of the Greene questionnaire on climacteric symptoms. Patients had to assign a score from 0 to 3 based on the presence and frequency of the listed disorders: less than 7 hot flashes per day, sweating, decreased libido, vaginal dryness, mood, fatigue, arthralgia, general myalgia, insomnia.
Le pazienti sono state trattate per tre mesi con un prodotto a base di Dioscorea villosa, Trifoglio rosso, Resveratrolo. Il prodotto aveva una formulazione in gel ed è stato applicato due volte al giorno in zona sub-ombelicale. Dopo tre mesi di trattamento le pazienti sono state sottoposte ad un nuovo esame comprendente la storia, l'esame fisico, una nuova compilazione del questionario Greene sui sintomi climaterici e dato un punteggio da 0 a 3 secondo per la presenza e la frequenza dei sintomi indagati: vampate al giorno, sudore, diminuzione della libido, secchezza vaginale, umore, affaticamento, artralgia, mialgia generale, insonnia. The patients were treated for three months with a product based on Dioscorea villosa, Red Clover, Resveratrol. The product had a gel formulation and was applied twice a day in the sub-umbilical area. After three months of treatment, the patients underwent a new examination including history, physical examination, a new completion of the Greene questionnaire on climacteric symptoms and given a score of 0 to 3 seconds for the presence and frequency of the symptoms investigated. : daily flushing, sweating, decreased libido, vaginal dryness, mood, fatigue, arthralgia, general myalgia, insomnia.
2.2 Risultati 2.2 Results
Dopo 3 mesi di trattamento, le donne che hanno ricevuto la terapia hanno mostrato un miglioramento generale di quasi tutti i sintomi clinici indagati ed una riduzione significativa del punteggio Greene Climateric. È stata osservata una significativa riduzione delle vampate di calore e sudorazione già dopo una media di sette giorni di terapia. E’ stata osservata anche una riduzione significativa dell’astenia ed insonnia. Uguali miglioramenti anche se più lenti si sono avuti sulla libido e secchezza vaginale. In diversi casi è stata osservata riduzione delle artralgie e mialgie, sintomi iniziali meno frequenti rispetto ai precedenti. After 3 months of treatment, the women who received the therapy showed an overall improvement in almost all clinical symptoms investigated and a significant reduction in the Greene Climateric score. A significant reduction in hot flashes and sweating was observed after an average of seven days of therapy. A significant reduction in asthenia and insomnia was also observed. Equal improvements, albeit slower, were seen on libido and vaginal dryness. In several cases, a reduction in arthralgia and myalgia was observed, initial symptoms less frequent than the previous ones.
Diverse pazienti hanno dimostrato una riduzione della perdita di peso dovuta alla ritenzione idrica, migliorando il trofismo della pelle. Il trattamento è stato seguito con facilità da tutti i pazienti e non ci sono stati effetti collaterali. Several patients have demonstrated a reduction in weight loss due to water retention, improving the trophism of the skin. The treatment was easily followed by all patients and there were no side effects.
2.3 Conclusioni 2.3 Conclusions
L'associazione Dioscorea (Diosgenina), Trifoglio rosso e Resveratrolo è un'ottima alternativa per il trattamento di disturbi climaterici sia per gli effetti osservati che per l’alta compliance del paziente in quanto il gel diventa un'attività quotidiana nella cura personale. I risultati eccellenti raggiunti sulla qualità della vita delle pazienti indica l’efficacia di questo trattamento. The Dioscorea (Diosgenin), Red Clover and Resveratrol combination is an excellent alternative for the treatment of climacteric disorders both for the observed effects and for the patient's high compliance as the gel becomes a daily activity in personal care. The excellent results achieved on the quality of life of patients indicate the effectiveness of this treatment.
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| WO2001070212A2 (en) * | 2000-03-23 | 2001-09-27 | Interhealth Nutraceuticals Incorporated | Method and composition for preventing or reducing the symptoms of menopause |
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| WO2001070212A2 (en) * | 2000-03-23 | 2001-09-27 | Interhealth Nutraceuticals Incorporated | Method and composition for preventing or reducing the symptoms of menopause |
| US20030170325A1 (en) * | 2002-01-04 | 2003-09-11 | Harold Mermelstein | Composition and method for treatment of vaginal dryness |
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